Events

Recall of PHILIPS INTELLISPACE PACS

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by PHILIPS ELECTRONICS LTD..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    21581
  • Event Risk Class
    II
  • Event Initiated Date
    2013-10-17
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Philips healthcare has become aware of a potential problem with the philips intellispace pacs system. there is a software issue which in certain circumstances could result in the unintended deletion of images sent to the intellispace pacs 4.4 system before they are available for access by system users. timing of iages being received by the pacs varies based on study size or modality configuration. if additional images are received into the study input folder as the input folder is being deleted those images are not saved and can result in missing images.

Device

PHILIPS INTELLISPACE PACS
  • Model / Serial
    Model Catalog: INTELLISPACE PACS 4.4 (Lot serial: N/A)
  • Product Description
    PHILIPS HEALTHCARE INFORMATICS INC
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

PHILIPS ELECTRONICS LTD.
  • Manufacturer Address
    MARKHAM
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    HC